ksb-d08-k0032

name	KSB-D08-K0032
description	Investigation Protocol Development: Standardized investigation procedures, evidence collection frameworks, external expert consultation ...
version	1.0.0
domain	D08
domain_name	Signal Detection & Management
type	Knowledge
proficiency_level	L3
bloom_level	apply
triggers	["explain investigation protocol development","what is investigation protocol development","apply investigation protocol development"]
epa_mapping	EPA-04, EPA-05
cpa_mapping	CPA-02
regulatory_refs	FDA-GUID-006, EMA-GVP-005, EMA-GVP-010, CIOMS-VIII

KSB-D08-K0032: Investigation Protocol Development

Overview

Domain: D08 - Signal Detection & Management Type: Knowledge Proficiency Level: L3 (Competent - Minimal supervision) Bloom Level: Apply

Description

Standardized investigation procedures, evidence collection frameworks, external expert consultation processes, timeline management systems

Context

• Major Section: Signal Management Workflow and Communication Systems
• Section: Systematic Signal Management Framework

EPA Mapping

• EPA-04:3009-3010
• EPA-05:3011-3012

CPA Pathway

• CPA-02

Regulatory References

• FDA-GUID-006
• EMA-GVP-005
• EMA-GVP-010
• CIOMS-VIII

Instructions

When this skill is activated, Claude should:

1. Demonstrate L3 proficiency in investigation protocol development
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (FDA-GUID-006, EMA-GVP-005, EMA-GVP-010, CIOMS-VIII)
4. Connect to related EPAs: EPA-04, EPA-05

Key Competencies

• Standardized investigation procedures, evidence collection frameworks, external expert consultation processes, timeline management systems

Assessment Criteria

• Can apply core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D08 skills in Systematic Signal Management Framework
• Cross-domain integrations per DAG architecture

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Generated from PV KSB Framework v1.0 | 2025-12-31